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Completed

NCT Number: NCT02931045

Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction

Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced infection-related mortality compared to clopidogrel, previous standard treatment for patients with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant platelet extracellular vesicles. The investigators assume that decrease in infection-related mortality in patients treated with ticagrelor may be explained by greater inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected to identify an additional mechanism of action of ticagrelor, which might contribute to the observed clinical benefits in patients treated with ticagrelor.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Infarction Inflammation Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laboratory of Experimental Clinical Chemistry, Academic Medical Centre of the University of Amsterdam, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Informed consent to participate in the study
  • Percutaneous coronary intervention with stent implantation due to first S T elevation myocardial infarction, or first non S T -elevation myocardial infarction
  • Administration of a loading dose of clopidogrel

Exclusion criteria

  • Known coagulopathy
  • Known history of bleeding disorder
  • Suspicion of intracranial haemorrhage
  • Need for oral anticoagulation therapy
  • Administration of glycoprotein (GP) II b - III a antagonists
  • Cardiogenic shock
  • Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
  • Severe liver insufficiency
  • Chronic dyspnea
  • Increased risk of bradycardia
  • Autoimmune disease
  • Infectious disease
  • Neoplasms
  • Pregnancy
  • Study drug intolerance
  • Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors
  • Participation in any previous study with ticagrelor or clopidogrel

Treatment and study plan

Ticagrelor

Drug

Comparison of ticagrelor with another antiplatelet drug (clopidogrel)

Other names: Brilique

clopidogrel

Drug

Comparison of clopidogrel with another antiplatelet drug (ticagrelor)

Other names: Plavix

Primary outcomes

  1. Concentration of Platelet Extracellular Vesicles/ml

    Time frame: 6 months following the beginning of antiplatelet therapy

    Concentration of platelet extracellular vesicles/ml measured with flow cytometry

Secondary outcomes

  1. Concentration of Extracellular Vesicles Exposing Fibrinogen

    Time frame: 6 months

    Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry

  2. Concentration of Extracellular Vesicles Exposing Phosphatidylserine

    Time frame: 6 months

    Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry

  3. Concentration of Extracellular Vesicles From Endothelial Cells

    Time frame: 6 months

    The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry

  4. Concentration of Extracellular Vesicles From Leukocytes

    Time frame: 6 months

    Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry information

Official study title

Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction

Acronym: AFFECT EV

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 12, 2016
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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